FDA 510(k) · Somnomedics
K081485: SOMNOWATCH (Somnomedics GmbH)
Somnomedics GmbH received FDA 510(k) K081485 for SOMNOWATCH, with a decision date of Sep 18, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K081485 |
|---|---|
| Pathway | 510(k) |
| Applicant | Somnomedics GmbH |
| Device name | SOMNOWATCH |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | May 28, 2008 |
| Decision date | Sep 18, 2008 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances. Intended Use The SOMNOwatch is a small, typically wrist-worn activity monitor. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly associated to movement-correlated sleep disturbances. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desired. For PLM-detection two identical SOMNOwatches may be affixed to the patients legs, one to each leg. Technical Specifications of the SOMNOwatch CHANNELS 6 Internal Channels: (3 Activity Sensors for X-Y-Z Axis, Body Position, Ambient Light, Patient Marker) DATA PROCESSING 12 Bit ADC Different Sampling Rates Adjustable (1/1 20s - 128/s) Different Storage Rates Adjustable (1/120s - 128/s)
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Wrist PPG. These are heuristics, not FDA fields.